International Journal of Engineering Applied Sciences and Technology, 2023

Vol. 8, Issue 07, ISSN No. 2455-2143, Pages 56-63

Published Online November 2023 in IJEAST (http://www.ijeast.com)

THE IMPORTANCE OF QUALITY

MANAGEMENT SYSTEM IN
PHARMACEUTICAL INDUSTRY
Richa Shukla
Department of Quality Assurance
Indore Institute of Pharmacy
Indore, Madhya Pradesh, India

Gurmeet Singh Chhabra

Department of Quality Assurance (HOD)
Indore Institute of Pharmacy
Indore, Madhya Pradesh, India

Abstract: One of the businesses with the most regulations A formalized system that records duties, processes, and
is the pharmaceutical industry. Implementing a quality procedures for accomplishing quality policies and objectives
management system helps the pharmaceutical business is known as a quality management system, or QMS. A QMS
deliver high-caliber finished goods to the market. aids in organizing and directing an organization's operations
Quality management system has played an important to satisfy legal and customer requirements and continuously
role in producing a high quality of produced yield as enhance its efficacy and efficiency. [2]
well as it is more supportive in managing, balancing and
continuing the quality status in their services or II. QUALITY IN PHARMACEUTICAL INDUSTRY
products. This review article goes into detail about the Since Quality directly affects the revenues from sales,
ICH Q10, their purpose, history, GLP and ISO. This quality is a crucial necessity for items in any business. There
review article also covers audits, QMS, their is, nevertheless, one more significant reason why high-
implementation, risk management, certification and quality products are required in the pharmaceutical sector.
industrial influence on standards and quality. This This is really one of the main causes of this industry's
review article in short covers all the important and extreme regulation, as any mistakes made during the
valuable aspects of QMS from how is QMS implemented production process could have harmful or even lethal effects
and what are its effects on industrialization and its audit on the patients who consume the products. Pharmaceutical
and certification. items must therefore be produced in a way that satisfies
strict regulatory requirements. [3]
Keywords - Quality management, ICH Q10, QMS, GLP, Quality cannot be adequately described in one word. Each
CIP, Pharmaceutical industry. individuality can define it in their own unique way. The
satisfaction is the sole factor that unites them all. The
I. INTRODUCTION product must fulfill the manufacturer's requirements.
The context of quality has become significant in the current Consequently, a product's ability to fulfill requirements is a
situation. In general, "quality" refers to a factor that measure of its quality. Since pharmaceutical items are
determines whether a good or service is superior or poor. intended for human use, quality should not be compromised.
Comprehending the extent to which a product fulfills its Thus, the product's identification, safety, chastity, and
criteria is a gauge of quality. quality are required. Vibrant recommendations recommend
Since pharmaceutical products are directly injected into the that each pharmaceutical association adhere to certain
bodies of its consumers, identity, purity, safety, and finally standards and regulations. The highest quality position is
the right product quality are vitally important. This makes guaranteed with fewer recall or unfavorable occurrences
quality control in the pharmaceutical industry a crucial when the fundamentals of the quality operation system are
topic. Every pharmaceutical sector is required to adhere to a used. [4]
number of global guidelines that have established norms or
criteria.

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 International Journal of Engineering Applied Sciences and Technology, 2023
Vol. 8, Issue 07, ISSN No. 2455-2143, Pages 56-63
Published Online November 2023 in IJEAST (http://www.ijeast.com)

A. History of Quality Management System - team work and the hard work, especially for the problems
There has been a possibility that certification of a Quality coming through a continuous improvement cycle.
Management System does not guarantee stakeholders that And today, in the very 21st century, QMS is twinning with
goods or services will be supplied to the customer on time sustainability and transparency concepts, so both investor
since the introduction of the ISO series of quality and customer satisfaction and quality are related to these
management standards in 1987. QS-9000 was launched in factors. [5]
1995 with the expectation that things would improve.
Ultimately, all of these had the same objective of satisfying IV. ICH Q10
customers by providing high-quality goods or services on The full form of ICH is “International Conference on
schedule. What the organizations fail to recognize or Harmonization of Technical Requirements for Registration
comprehend is that their qualification now allows them to of Pharmaceuticals for Human Use.” [10]
grasp the correct things. This body was established to examine technical and
In 1924, Walter A. Shewhart made a significant contribution scientific elements of drug registration by bringing together
to the field of quality management when he developed a representatives of regulatory agencies and the
statistically based system for industrial quality control. His pharmaceutical sector. Drug manufacturers had to invest a
work on statistical quality control was built upon this. [7] lot of time and money on repeating test procedures in order
During World War II, W. Edwards Deming employed to market their goods internationally due to the disparities in
statistical process control techniques in the US to improve technical standards across nations as the pharmaceutical
the quality of weapons and other critical products business became increasingly global. Ensuring that patients
manufactured. worldwide have access to safe and effective medications
Shewhart's theories were promoted in Japan starting in 1950 without delays resulting from regulatory bodies in different
by W. Edwards Deming. His management concept of countries adopting inconsistent policies has become
establishing competitive position, productivity, and quality increasingly crucial. As a result, there was a need to
is what made him most famous. He came up with 14 points. integrate and rationalize drug rules, which led to the
creation of ICH in 1990. [2,6]
These fourteen principles cover important ideas like:
• No departmental barriers. The goal of ICH can be summed up as follows:
• Management should take on duties and exercise rule • Guaranteeing the efficacy, safety, and quality of
leadership. pharmaceuticals.
• Supervision should be for the assistance of people and • Standardization of medication technical specifications.
machines and other devices to facilitate work. • Prevent doing duplicate human clinical trials.
• Constantly and always improve production and service. • Minimize the utilization of animal testing while
• Establish a program for education and self- maintaining the integrity of drug safety and efficacy
improvement. assessments. [2,6]
In the field of quality, Philip Crosby—known as the Guru of
Quality Management—was a legendary figure. The greatest A. History of ICH -
quality expert, advisor, and writer, he is best known for A technical prerequisite for medications intended for human
advocating for "zero defects" and characterizing quality as consumption is the International Council for Harmonization
requirement compliance. [5,7] (ICH). Bringing the pharmaceutical industry and regulatory
bodies together to discuss the scientific and technical
III. DEFINING QUALITY MANAGEMENT aspects of drug registration is a novel step. Since its
The resources, methods, procedures, and organizational establishment in 1990, ICH has progressively changed to
structure required to accomplish quality management are address the increasingly global nature of drug research. The
collectively referred to as a quality management system International Conference on Harmonization (ICH), formerly
(QMS). [9] known as the International Council for Harmonization
In other words, a quality management system is a set of (ICH), conducted its first assembly meetings on October 23,
interrelated components that organizations use to direct and 2015, thus established the ICH as a legal organization under
control how quality policies and processes are regulated and Swiss law and an international association.
quality objectives are successfully achieved. [6] The goal of ICH is to increase global harmonization in order
Quality management is a activity run by everyone in an to guarantee that high-quality, safe, and effective
organization, governed by Executive management and medications are developed and registered in the most
regulated by the Quality Management Department. resource-efficient way possible. [3,6]
However, by the 20th century, labor were the most costly
subjects in most of the industrial matter, so it lead to the

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 International Journal of Engineering Applied Sciences and Technology, 2023
Vol. 8, Issue 07, ISSN No. 2455-2143, Pages 56-63
Published Online November 2023 in IJEAST (http://www.ijeast.com)

B. Q10: pharmaceutical quality system - nations, and promotes free and equitable international trade.
It is a management system to direct and control a [5]
pharmaceutical company with regard to quality. ICH Q10 is
based upon ISO 9000: 2005. [10] A. Development of ISO Standards -
The basis for ICH Q10 is the relationship between ISO A technical committee's group of specialists creates an ISO
standards, ICH Q7 guidelines, or "Good manufacturing standard. After determining the necessity for a standard,
practice guide for active pharmaceutical ingredients," and these experts get together to debate and negotiate a draft
regional GMP regulations. Additionally, ICH Q7 guidelines standard. Once a draft has been created, it is shared with
and ISO quality management system recommendations are ISO members, who are then requested for feedback and a
related to each other. ICH Q10 supplements GMPs by vote. The draft becomes an ISO standard if agreement is
outlining particular quality system components and reached; otherwise, it is sent back to the technical
management roles in order to achieve the goals listed below. committee for additional revisions.
In addition to regional GMP regulations, ICH Q10 offers a ISO has many management system standards, each focuses
harmonized model for a pharmaceutical quality system on different issues, some of are these:
throughout a product's lifecycle. [12] • ISO 50001 – Energy Management
It is not specifically stated in the regional GMPs that every • ISO 9001 – Quality Management
phase of the product lifecycle is covered (such as growth). • ISO 14000 – Environmental Management
The goal of the quality system components and management • ISO 22000 – Food Safety Management. [5]
duties outlined in this guideline is to promote continuous
improvement across the whole product lifecycle by VI. MISSION STATEMENT FOR THE QUALITY
encouraging the application of science and risk-based MANAGEMENT SYSTEM
techniques at every step of the lifecycle. [3]
The criteria of the ISO 9001 standards mandate that
C. Definition of GLP – organizations create a QMS Quality Policy that will allow
"GLP," as defined by the FDA, is a collection of rules them to manage, control, and improve organizational
intended to guarantee the quality and objectivity of non- processes in order to ensure that services and goods meet
clinical laboratory investigations meant to support research customer requirements. This policy will help organizations
or marketing authorizations for products overseen by determine their objectives and quality policy. For instance:
government bodies. [15] [5]
An in-vitro or in-vivo experiment where the product under Our Principles - We adhere to the following principles:
evaluation is tested in systems in a lab environment to Confidentiality, discretion, trust, propriety, and honesty.
ascertain its level of safety is called a non-clinical laboratory • Our clients: We strive to give our clients the best
investigation. service possible since we know that in order to succeed,
Consequently, GLP ensures that testing facilities fulfill the they must remain loyal and supportive over the long term.
FDA's minimal requirements for the planning, carrying out, • Our connections: With our employees, clients, and
and sharing of safety studies related to non-clinical testing. suppliers, we establish long-term relationships that are
GLP provides a rigorously regulated study framework that mutually beneficial.
guarantees full accountability. [2] • Our employees: We treat them with respect and
decency and are dedicated to assisting them in realizing
V. ISO FAMILY their full potential via training and development. They are
also urged to take part in choices that affect their day-to-day
According to the International Organization for work activities.
Standardization, which creates and publishes international
• Ideas: We encourage our employees, clients, and
standards:
suppliers to use innovation and creativity to solve issues and
“A standard is a set of rules, guidelines, specifications, or
capture opportunities.
other qualities that can be applied consistently to guarantee
• Quality: We endeavor to create a culture where quality
the suitability of materials, goods, procedures, and
come.[5]
services.” [11]
The goal of the ISO International Standards is to guarantee
VII. IMPLEMENTATION OF QUALITY
the quality, dependability, and safety of goods and services.
MANAGEMENT SYSTEM
These standards are tactical instruments used in the
corporate world to assist cut expenses by reducing waste A. Decide what your company wants to accomplish.
and errors and boosting efficiency. It enables businesses to Examples include –
enter new markets, evens the playing field for emerging • becoming more effective and profitable;

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 International Journal of Engineering Applied Sciences and Technology, 2023
Vol. 8, Issue 07, ISSN No. 2455-2143, Pages 56-63
Published Online November 2023 in IJEAST (http://www.ijeast.com)

• producing goods and services that consistently satisfy B. Determine the expectations that others have of your
customers; company –
• increasing market share; • Clients and end users;
• maintaining market share; • Staff;
• enhancing internal communications and morale; • Vendors;
• lowering costs and liabilities; • Shareholders;
• And increasing trust in the production system. [5, 8] • Society. [5, 8]

Fig 1. Ten step approach for QMS implementation

VIII. THE 8 PRINCIPLES OF QUALITY 2. Second principle: leadership

MANAGEMENT SYSTEM Leaders set the direction of the organization and create a
1. First principle: client attention sense of unity. Workers must create and preserve a positive
Businesses must understand their customers' needs both work environment if they are to actively contribute to
now and in the future, meet their requests, and strive to go achieving the organization's goals.
above and beyond their expectations because they are their
lifeblood. 3. Third principle: Involvement of humans
People are an organization's most important asset, and when
they participate fully, their skills may be used to the
organization's benefit.

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 International Journal of Engineering Applied Sciences and Technology, 2023
Vol. 8, Issue 07, ISSN No. 2455-2143, Pages 56-63
Published Online November 2023 in IJEAST (http://www.ijeast.com)

Examples of typical risk categories whose effects

4. Fourth principle: process-oriented approach management can influence include:
A more efficient way of achieving the intended outcome is • Accidents that occur at work
to handle activities and related resources as a process. • Severe weather events including fires, tornadoes,
floods, and earthquakes
5. Fifth principle: a systemic management strategy • Financial unpredictability, project failure, credit
The identification, understanding, and management of a hazards, data storage, and security are legal concerns in
network of interrelated activities toward a common goal addition to supply chain disruption.
increases the effectiveness and efficiency of the • Other risks include fraud, theft, and sexual harassment.
organization. An organization's processes and their There are as many methods for lowering or removing risk as
interdependencies need to be defined in order to manage it there are risk factors. the four primary strategies listed
successfully. below:
• Remain mute and accept the outcome.
6. Sixth principle: ongoing development • The transfer of risk to a third party is known as
The long-term objective of the company need to be to insurance.
consistently raise its overall performance. • Eliminate risk by shutting down troublesome
departments inside the company.
7. Seventh Principle: Making decisions based on facts
Every business should execute a risk management strategy
The fact-based approach to decision-making philosophy
since doing so is the appropriate course to follow in order to
states that the analysis of data and information is the
sustain a successful business that safeguards its clients,
foundation for making effective judgments. partners, and material assets. [5]
8. Eighth principle: supplier relationships that benefit
X. CONTINOUS IMPROVEMENT PLAN
both parties
Value creation by a business and its suppliers is Plans for continuous quality improvement, or CIPs, are
interconnected, and a win-win collaboration makes that programs created to examine particular circumstances and
capacity stronger. [5] propose methods for upgrading or improving all associated
elements. [14]
IX. RISK MANAGEMENT IN ORGANIZATION In almost any company environment, policies and
procedures may be evaluated using a continuous
The importance of risk management in today's business
improvement method.
world is only growing. You can no longer rely on corrective
The idea is to improve upon what is already excellent in
action being taken after a problem arises. The reputation of order to benefit the business as a whole.
your business as a provider of high-quality goods or
W. Edwards Deming, considered it to be a component of
services may be irreparably harmed in today's era of instant
the 'system' that assessed customer and process feedback in
information technology before you can take corrective relation to corporate objectives. The fact that it can be
action. What steps can you take to lessen this possibility?
referred to as a management process does not entail that
Plan for risk management!
'management' must carry it out; rather, it only indicates that
it makes decisions regarding the delivery process's
Risk management seeks to shield businesses from
implementation and design.
vulnerability.
The (self) reflection of processes is the central tenet of CIP.
The first steps in the risk management process are to
(feedback)
identify, evaluate, and prioritize potential hazards. Taking
The discovery, mitigation, and abolition of suboptimal
steps to reduce or eliminate the effects of unfortunate events
processes are the goals of CIP. (efficiency)
is the next step in the process. [5]
The focus of CIP is on continuous, incremental progress
rather than huge leaps. (Evolution) [5]

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 International Journal of Engineering Applied Sciences and Technology, 2023
Vol. 8, Issue 07, ISSN No. 2455-2143, Pages 56-63
Published Online November 2023 in IJEAST (http://www.ijeast.com)

Fig.2.The PDCA cycle

XI. INDUSTRIAL IMPACT ON STANDARDS AND B. Other quality management standards, such as ISO
QUALITY 9001:2015 -
Early quality management systems were employed as The most widely used and accepted quality management
benchmarks to regulate the outputs of processes and system standard in the world is unquestionably ISO
products during the Industrial Revolution. Best practices 9001:2015. Companies can use the ISO 9001:2015 QMS
were required to guarantee high-quality results when more criteria to create their own programs. ISO 9000 and ISO
individuals had to collaborate to achieve results and 9004 are two more ISO 9000 family standards that provide
production volumes increased. Best practices for regulating additional guidance for quality control systems.
the results of processes and products were eventually Environmental management systems follow ISO 14000
developed and recorded. These well-documented best guidelines.
practices become the norm for quality control systems. [1] • Medical device quality management systems are
covered by ISO 13485,
A. The Development of Quality Management Systems - • Auditing management systems are covered by ISO
Total quality operation (TQM), a strategy for quality 19011, and
operation that stressed not only data but also ways that • Automotive industry-related products are covered by
embraced the entire association, was created as an American ISO/TS 16949. [1]
response to the quality revolution in Japan. Independent
associations started developing guidelines to aid in the C. Advantages of quality control procedures -
development and implementation of high-quality An organization's performance is impacted in every way by
operational systems in the latter half of the 20th century. the implementation of a quality management system.
The name "Quality Management System" or "QMS" is Designing and implementing written quality management
favored due to the vast array of distinctive systems that can systems has two main advantages, which are as follows:
be used. As the twenty-first century got under way, QMS 1. Fulfilling the client's needs helps to build the client's trust
started to integrate with the concepts of transparency and in the company, which in turn encourages additional clients,
sustainability as these concepts started to lose significance sales, and repeat business.
in terms of customer pleasure. Both quality and 2. Fulfilling the organization's criteria, which guarantees
sustainability are addressed by the ISO 19011 inspection regulatory compliance and ensures the success of goods and
governance, as is their incorporation into associations. [1] services in the most resource- and cost-efficient way,
allowing for room for expansion, growth, and profit. Within
these, there are advantages like assisting in communicating
a willingness to deliver consistent outcomes, preventing
errors, lowering expenses, making sure that procedures are

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 International Journal of Engineering Applied Sciences and Technology, 2023
Vol. 8, Issue 07, ISSN No. 2455-2143, Pages 56-63
Published Online November 2023 in IJEAST (http://www.ijeast.com)

specified and controlled, and consistently enhancing the Quality audits should not only highlight areas of best
organization's services. [1] practice for the organization but also reveal non-
conformances and corrective actions. As a result, other
XII. THE AUDIT departments may exchange information and modify their
An internal, external, or audit team will typically conduct a operational procedures, furthering the goal of continuous
quality audit, which is the act of methodically analyzing the development. [5]
quality management system of a company.
In order to guarantee that a company has clearly defined There are four steps in the audit process:
internal system monitoring methods connected to successful 1. Planning - designate auditors, settle on an audit program,
action, quality audits are often conducted at certain compile and examine all supporting paperwork, and create a
intervals. Audits test a quality management system's checklist.
suitability and proper execution. This might involve either 2. Performance - open meeting, audit, meeting of the audit
procedural or results-based assessment criteria, and it can team, and meeting adjournment.
help establish whether the organization adheres to the 3. Reporting - an audit report must be finished and given to
defined quality system processes. the auditee within fourteen days of the audit's conclusion.
4. Follow-up - found non-conformances need to be fixed.
[5]

Fig.3. The flowchart of audit process.

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 International Journal of Engineering Applied Sciences and Technology, 2023
Vol. 8, Issue 07, ISSN No. 2455-2143, Pages 56-63
Published Online November 2023 in IJEAST (http://www.ijeast.com)

XIII. THE CERTIFICATION Journal of Innovative Science, Engineering &

The process of having a third party's compliance with Technology, Vol.7, Issue 2, (pp. 99-107).
particular requirements verified by an impartial, certified [5]. Landerville T., (2013) "Quality Management
entity is known as certification, ISO does not certify Systems Guide", Santa Rosa, California;
organizations by itself. Isocert Solutions LLC,(pg. 1-26).
There are many certification agencies that examine [6]. Pandey P. and Goyal A., (January 11, 2018),
businesses and, if successful, provide certifications of ISO “Quality Management System in Drug Industry: A
9001 compliance. The real standard to which a company's Review”, Biomedical Journal of Scientific &
quality management system can be certified is ISO Technical Research, Volume 2- Issue 1, DOI:
9001:2008, despite the name "ISO 9000" being used 10.26717/BJSTR.2018.02.000653, (pp. 2177-
frequently in reference to it. To approve ("accredit") the 2179).
certification bodies, numerous nations have established [7]. Zanje Abhijit L., and Jadhav Vaibhav A., (June
accreditation agencies. To guarantee that certificates issued 2022), “A Review of Total Quality Management in
by one of the accredited certification bodies (CBs) are Pharmaceuticals”, International Journal of
recognized globally, the various accreditation bodies have Research Publication and Reviews, Vol 3, no 6, (pp
bilateral agreements with one another. [13] 2401-2409).
[8]. Mourougan S., and Sethuraman K., ((May. 2017),
XIV. CONCLUSION “Understanding and Implementing Quality
Management System”, IOSR Journal of Business
There is no single definition of the word quality. People and Management, Volume 19, Issue 5. Ver. I, DOI:
define it in different ways since it is tensile, yet all 10.9790/487X-1905014151, (pp 41-51).
definitions have the quality of satisfaction. When a product [9]. https://en.wikipedia.org/wiki/Quality_management
satisfies a customer's need, the manufacturer is glad since it _system
has met its specifications. Quality, however, is a modern [10]. https://en.wikipedia.org/wiki/International_Council
necessity that cannot be ignored. When it comes to the _for_Harmonisation_of_Technical
pharmaceutical industry, quality is a legal concern that must Requirements_for_Pharmaceuticals_for_Human_U
be upheld in pharmaceutical products. The focus of the se
current study is on a few issues and the necessity of [11]. https://en.wikipedia.org/wiki/International_Organiz
sustaining pharmaceutical quality through a quality ation_for_Standardization
management system. In order to produce a quality, safety [12]. https://en.wikipedia.org/wiki/Good_manufacturing
and zero-defect product at an economical rate, the _practice
implementation of quality management system is very much [13]. https://en.wikipedia.org/wiki/Certification
essential in pharmaceutical sector. Also, this principle is [14]. https://en.wikipedia.org/wiki/Continual_improvem
very much important aspect towards the minimization or ent_process
complete removal of any type of defects or dangerous [15]. https://en.wikipedia.org/wiki/Good_laboratory_pra
contaminations which are occurring in the microbiological ctice
pharmaceutical production.

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